ID

16624

Description

Sponsor: OSI Pharmaceuticals Information provided by (Responsible Party): Astellas Pharma Inc ( OSI Pharmaceuticals ) A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent Tarceva® (erlotinib) following complete tumor resection with or without adjuvant chemotherapy in patients with stage IB-IIIA non-small cell lung carcinoma who have EGFR-positive tumors. See https://clinicaltrials.gov/ct2/show/NCT00373425 Study Drug Administration

Lien

https://clinicaltrials.gov/ct2/show/NCT00373425

Mots-clés

  1. 27/07/2016 27/07/2016 -
  2. 01/08/2016 01/08/2016 -
Téléchargé le

27 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0

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Test A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

Study Drug Administration A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

Header
Description

Header

Site Number
Description

Site number

Type de données

integer

Alias
UMLS CUI [1,1]
C0018704
UMLS CUI [1,2]
C0600091
Patient Number
Description

patient number

Type de données

integer

Alias
UMLS CUI [1]
C1830427
Study Drug Administration
Description

Study Drug Administration

Start Date
Description

Study Drug Administration Start Date

Type de données

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Administered Dose
Description

Dose

Type de données

float

Unités de mesure
  • mg
Alias
UMLS CUI [1]
C0178602
mg
Stop Date
Description

Study Drug Administration Stop Date

Type de données

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Dose Modification (Record toxicities on the Adverse Events page.)
Description

Study Drug Dose Modification

Type de données

integer

Alias
UMLS CUI [1]
C1707811
If other, specify:
Description

Study Drug Dose Modification

Type de données

text

Alias
UMLS CUI [1]
C1707811
Missed Doses (Record the number of missed doses, if any, for the time between the start and stop dates.)
Description

Missed Doses

Type de données

integer

Alias
UMLS CUI [1,1]
C1709043
UMLS CUI [1,2]
C0750480

Similar models

Study Drug Administration A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (RADIANT) NCT00373425

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Header
Site number
Item
Site Number
integer
C0018704 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
patient number
Item
Patient Number
integer
C1830427 (UMLS CUI [1])
Item Group
Study Drug Administration
Study Drug Administration Start Date
Item
Start Date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Dose
Item
Administered Dose
float
C0178602 (UMLS CUI [1])
Study Drug Administration Stop Date
Item
Stop Date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Item
Dose Modification (Record toxicities on the Adverse Events page.)
integer
C1707811 (UMLS CUI [1])
Code List
Dose Modification (Record toxicities on the Adverse Events page.)
CL Item
Drug-related Toxicity (AE) (1)
CL Item
Nondrug-related Toxicity (AE) (2)
CL Item
Patient Request  (3)
CL Item
Toxicity lmproved  (4)
CL Item
No Modification (5)
CL Item
Other (specify) (6)
Study Drug Dose Modification
Item
If other, specify:
text
C1707811 (UMLS CUI [1])
Missed Doses
Item
Missed Doses (Record the number of missed doses, if any, for the time between the start and stop dates.)
integer
C1709043 (UMLS CUI [1,1])
C0750480 (UMLS CUI [1,2])

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